NCT04229966

Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases

A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.

Detailed description

The incidence of Acute Epidural Hematoma (AEDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%. Most people with EDH are generally expected to have a good clinical outcome with the prompt and correct treatment. However, AEDH still represents a potentially life-threatening condition when a local mass effect exists due to rapidly elevated intracranial pressure (ICP) resulted from the rapid build-up of blood. Brain hernia and cerebral infarction might occur and lead to a terrible clinical outcome. In addition, there is a set of patients who experience clinical deterioration after an initial hematoma-evacuation craniotomy because of secondary brain injuries, including massive cerebral infarction (MCI), additional decompressive craniectomy is recommended as soon as possible. Although DC can reduce the morbidity and mortality in critically ill patients with a sTBI, the removal of the bone flap is not necessary for the majority of patients with AEDH, because of the relatively low incidence of MCI secondary to AEDH. Recommendations indicated an epidural hematoma greater than 30 ml should be surgically evacuated regardless of the patient's GCS score. Although craniotomy provides a complete evacuation to remove the clot of the hematoma, there are insufficient data to support a specific surgical treatment method. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. Therefore, there is a clinical rationale for investigating the current status of surgical treatments and prognosis for AEDH, thereby providing a reliable reference for the optimization of therapy.

Conditions

• Epidural Hematoma
• Decompressive Craniectomy
• Craniotomy

Timeline

• Start date: 2020-11-02
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-01-18
• Last updated: 2026-01-14

Locations

1 site across 1 country: China